Marbofloxacin should not be used in dogs aged less than 12 months or less than 18 months for exceptionally large breeds of dogs, such as Great Danes or Mastiffs with a longer growth period.
Do not use in cases of resistance to other fluoroquinolones (cross-resistance).
Do not use in cases of hypersensitivity to the active substance, to any other quinolones or to any of the excipients.
Special warnings for each target species
None.
Special Precautions for use in animals
Fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals.
Fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly or are expected to respond poorly to other classes of antimicrobials. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may reduce effectiveness of treatment with other quinolones due to the potential for cross-resistance.
Official and local antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product
People with known hypersensitivity to (fluoro)quinolones should avoid using this product.
In case of contact with skin or eyes, rinse with plenty of water.
Accidental self-injection can induce a slight irritation.
In case of accidental self-injection, seek medical advice and show the label to the doctor.
Wash hands after use.
Adverse reactions (frequency and seriousness)
After subcutaneous administration, no undesirable effect is observed up to 2 times the maximum recommended therapeutic dose in dogs or 3 times the maximum recommended dose for cats.
After i.v. administration at 4mg/kg, rare mild and transitory side effects have been reported:
- ptyalism (excess salivation)
- nervous disorders: vocalization, excitation, trembling (myoclonia).
- very rarely, hypersensitivity reactions, diarrhoea and vomiting have been reported
The frequency of adverse reactions is defined using the following convention:
Very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Official and local antimicrobial policies should be taken into account when the product is used
Interaction with other medicinal products and other forms of interaction
The dosage of theophylline must be reduced when used concurrently.
Overdosage may cause acute signs in the form of neurological disorders, hypersalivation or trembling which should be treated symptomatically.
After subcutaneous administration, no undesirable effect is observed up to 2 times the maximum recommended therapeutic dose in dogs or 3 times the maximum recommended dose for cats. After i.v. administration at 4mg/kg, rare mild and transitory side effects have been reported: -ptyalism (excess salivation) - nervous disorders: vocalization, excitation, trembling (myoclonia).
Withdrawal period
Not applicable.
Use during pregnancy and lactation
Studies carried out with laboratory animals showed no embryotoxic, foetotoxic or teratogenic effects. However, no specific studies have been carried out on pregnant cats or dogs.